通用名称

liraglutide

儿科标签批准日期

2019/6/17 0:00:00

特定指示/秒

Treatment of type 2 diabetes mellitus in pediatric patients ages 10 years and older

标签更改摘要

- Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. - Use for this indication is supported by a 26-week placebo-controlled clinical trial and a 26-week open-label extension in 134 pediatric patients 10 to 17 years with type 2 diabetes, a pediatric pharmacokinetic study, and studies in adults with type 2 diabetes mellitus. - Safety and effectiveness have not been established in pediatric patients less than 10 years of age. - The risk of hypoglycemia was higher with Victoza in pediatric patients regardless of concomitant antidiabetic therapies. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - Postmarketing study.

治疗类别

Hyperglycemic Agents

立法类型

PREA + BPCA

产品说明书链接

书号

1.0

研究年龄

10 YEARS - 17 YEARS

学习类型

Efficacy,Safety

研究设计

Multicenter,Randomized,Double-Blind,Parallel Group,Placebo Control

登记的患者

135

患者分析

134

中心的数量

84

国家数量

25

西班牙裔拉美裔/拉丁裔总计

39

非西班牙裔/非拉丁裔总人数

95

总数#种族不明

0

亚裔学生总数

18

黑人总数

16

白人总数

87

夏威夷或太平洋岛民总数

0

美洲印第安人/阿拉斯加本地人总数

3

其他种族总计

10

未知种族总数

N/A

国家

N/A